FDA.reportPublic FDA data

prednisone

Product NDC
76420-414
11-digit product format
764200414
Labeler code
76420
Product ID
76420-414_4c2b2c5f-3f84-9799-e063-6294a90a37cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA208412
Marketing category
ANDA
Marketing start
2022-05-24
Substance
PREDNISONE
Active strength
50 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
prednisone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198145, 198148, 312615

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2205d503-be51-445b-bb34-c209cc557b3cProduct name520230105
9492a99d-61c8-491f-9086-1c6a7e98c040Product name620230105
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-414-01prednisone100 in 1 BOTTLETABLET1004
76420-414-05prednisone5 in 1 BOTTLETABLET54
76420-414-10prednisone10 in 1 BOTTLETABLET104
76420-414-18prednisone18 in 1 BOTTLETABLET184
76420-414-20prednisone20 in 1 BOTTLETABLET204
76420-414-21prednisone21 in 1 BOTTLETABLET214
76420-414-30prednisone30 in 1 BOTTLETABLET304
76420-414-60prednisone60 in 1 BOTTLETABLET604
76420-414-90prednisone90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-414-01EA - Each76420-414c53bd03d-d2a6-4aeb-bfcd-bbaacac7fbd812026-03-17
76420-414-05EA - Each76420-4144ad34aae-b2a1-4422-849a-68ca97f6397412026-03-17
76420-414-10EA - Each76420-414aed519af-7b47-4ce8-a486-3bb72439f30f12026-03-17
76420-414-18EA - Each76420-414fe14bacd-47ad-48a9-bd77-b4c33243b1a912026-03-17
76420-414-20EA - Each76420-4142b16c3b8-0bc3-4195-bfe8-9c5ef7358e7e12026-03-17
76420-414-21EA - Each76420-414ab0da36c-c5e6-4a6b-8ad2-2ce585de26a912026-03-17
76420-414-30EA - Each76420-4147bba86b4-b0ea-4c14-8687-6652f2e590b012026-03-17
76420-414-60EA - Each76420-41408ba108e-544f-49d2-b0e6-5d546bc0601512026-03-17
76420-414-90EA - Each76420-414716d984d-e4ed-47e0-ac08-beb59b09420112026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNfdcf3271-fae7-47ef-a370-adbdc0a3cf374
312615predniSONE 20 MG Oral TabletPSNfdcf3271-fae7-47ef-a370-adbdc0a3cf374
198148predniSONE 50 MG Oral TabletPSNfdcf3271-fae7-47ef-a370-adbdc0a3cf374
198145prednisone 10 MG Oral TabletSCDfdcf3271-fae7-47ef-a370-adbdc0a3cf374
312615prednisone 20 MG Oral TabletSCDfdcf3271-fae7-47ef-a370-adbdc0a3cf374
198148prednisone 50 MG Oral TabletSCDfdcf3271-fae7-47ef-a370-adbdc0a3cf374

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-414-0176420041401100 TABLET in 1 BOTTLE (76420-414-01) 100 tablet2025-07-09NoNoHistorical
76420-414-05764200414055 TABLET in 1 BOTTLE (76420-414-05) 5 tablet2025-07-09NoNoHistorical
76420-414-107642004141010 TABLET in 1 BOTTLE (76420-414-10) 10 tablet2026-01-24NoNoHistorical
76420-414-187642004141818 TABLET in 1 BOTTLE (76420-414-18) 18 tablet2025-07-09NoNoHistorical
76420-414-207642004142020 TABLET in 1 BOTTLE (76420-414-20) 20 tablet2025-07-09NoNoHistorical
76420-414-217642004142121 TABLET in 1 BOTTLE (76420-414-21) 21 tablet2026-01-28NoNoHistorical
76420-414-307642004143030 TABLET in 1 BOTTLE (76420-414-30) 30 tablet2025-07-09NoNoHistorical
76420-414-607642004146060 TABLET in 1 BOTTLE (76420-414-60) 60 tablet2025-07-09NoNoHistorical
76420-414-907642004149090 TABLET in 1 BOTTLE (76420-414-90) 90 tablet2025-07-09NoNoHistorical